The US Food and Drug Administration (FDA), Health Canada and UK MHRA (June 13) built on their 2021 guiding principles for good machine learning practice for medical device development by further identifying guiding principles for transparency for machine learning-enabled medical devices (MLMDs).
As the healthcare sector continues to experience rapid proliferation of artificial intelligence (AI) and machine learning (ML)-enabled devices, the need to implement guidance that will safeguard the safety, effectiveness and transparency of such devices becomes ever more critical. This is particularly true as concerns the opaque nature of some AI/ML models and the potential for continuous evolution of learning algorithms.
Additional guidance on ML medical devices
These principles build upon principles 7 and 9 of the initial guiding principles:
- Principle 7: Focus is placed on the performance of the human-AI team
- Principle 9: Users are provided with clear, essential information
The principles emphasize a human-centered design (HCD), ISO 9241-210:2019 Ergonomics of human-system interaction - Part 210: Human-centered design for interactive systems, an “approach to systems design and development that aims to make interactive systems more usable by focusing on the use of the system and applying human factors/ergonomics and usability knowledge and techniques”.
Guiding principles
A summary of the guiding principles and relevance to transparency is outlined in the figure below. Because MLMDs can require the user and other stakeholders in the healthcare ecosystem to understand complex information that is often context-dependent, information must be provided that allows the user to identify and evaluate the risk and benefits associated with the device. Information should be provided with the intent of enhancing the audiences’ understanding of the device, its intended use and how it fits into the clinical workflow.
Additionally, information should be provided in simple terms demonstrating how the MLMD processes input information and reaches its output. This allows healthcare professionals and other stakeholders to critically assess this information, its validity and how it is utilized.
US FDA, Health Canada and UK MHRA Update on Transparency Guiding Principles for Machine Learning-Enabled Medical Devices
The US Food and Drug Administration (FDA), Health Canada and UK MHRA (June 13) built on their 2021 guiding principles for good machine learning practice for medical device development by further identifying guiding principles for transparency for machine l
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